FDA 510(k) Applications Submitted by Medtecs (Taiwan) Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K210414 02/11/2021 CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown Medtecs (Taiwan) Corp.
K203376 11/17/2020 ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G Medtecs (Taiwan) Corp.


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